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Site Start Up Associate - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresBulgaria,
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Site Start Up Associate

Nr ref.: /JOBS.pl

  • We're looking for a talented and energetic Site Start Up Associate to join our team!

    You'll be accountable for:

    Quality deliverables at the country level for site start-up in one or more components
    Forecasting submission/approval timelines and ensuring they are adhered to.
    Essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
    Progressing and tracking site recruitment and approvals according to study timelines
    Ensuring accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF
    Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees and other local bodies.
    Setting up and maintaining a country folder with country Ethics Committees and local authority addresses and requirements
    Documenting QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client

    You'll need this to be considered:

    BSc, MSc or equivalent
    Prior experience in Clinical Research with experience in start-up activities
    Prior experience using computerized information systems preferred
    Ability to read, write, and speak fluent English and Bulgarian
    Clinical trials support or pharmaceutical industry experience preferred
    Office based or homebased
    Knowledge of ICH and local regulatory authority drug research and development regulations preferred


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